Label: SENSITIVE TEETH- potassium nitrate paste
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Contains inactivated NDC Code(s)
NDC Code(s): 76098-001-01 - Packager: The Green Beaver Company Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 10, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- adults and children 12 years of age and older
- Apply at least a 1-inch strip of the product onto soft bristle toothbrush
- Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist
- Make sure to brush all sensitive areas of the teeth
- Children under 12 years of age: consult a dentist or doctor
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SENSITIVE TEETH
potassium nitrate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76098-001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) COCO GLUCOSIDE (UNII: ICS790225B) CALCIUM CARBONATE (UNII: H0G9379FGK) SORBITOL (UNII: 506T60A25R) XYLITOL (UNII: VCQ006KQ1E) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) XANTHAN GUM (UNII: TTV12P4NEE) MENTHA SPICATA (UNII: O2H83I4PUN) MENTHOL (UNII: L7T10EIP3A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76098-001-01 75 mL in 1 BOX; Type 0: Not a Combination Product 07/06/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 07/06/2017 Labeler - The Green Beaver Company Ltd. (243807018) Establishment Name Address ID/FEI Business Operations Dermolab Pharma Ltee 245414743 manufacture(76098-001)